Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Full Analysis Set(FAS):all randomized participants who received at least 1 dose of study treatment, had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using Non-Responder Imputation(NRI). 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 [Units: Percentage of participants]

41.67

48.12

24.43

Statistical Analysis 1 for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3

Groups [1]

CP-690,550 10 mg vs. Placebo

Method [2]

Normal Approximation

P Value [3]

<0.0001

Percentage Difference [4]

23.69

Standard Error of the mean

(5.73)

95% Confidence Interval

12.45 to 34.92

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.

[4]

Other relevant estimation information:

No text entered.

Statistical Analysis 2 for Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3

Groups [1]

CP-690,550 5 mg vs. Placebo

Method [2]

Normal Approximation

P Value [3]

0.0024

Percentage Difference [4]

17.23

Standard Error of the mean

(5.70)

95% Confidence Interval

6.06 to 28.41

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

Time Frame

Baseline, Month 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.

Additional details about the analysis, such as null hypothesis and power calculation:

LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.

Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3

Measure Description

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

Time Frame

Month 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 [Units: Percentage of participants]

6.72

11.20

1.67

Statistical Analysis 1 for Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3

Groups [1]

CP-690,550 10 mg vs. Placebo

Method [2]

Normal Approximation

P Value [3]

0.0017

Percentage Difference [4]

9.53

Standard Error of the mean

(3.05)

95% Confidence Interval

3.54 to 15.51

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in HAQ-DI had to be statistically significant.

[4]

Other relevant estimation information:

No text entered.

Statistical Analysis 2 for Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3

Groups [1]

CP-690,550 5 mg vs. Placebo

Method [2]

Normal Approximation

P Value [3]

0.0496

Percentage Difference [4]

5.05

Standard Error of the mean

(2.57)

95% Confidence Interval

0.00 to 10.10

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

Time Frame

Month 4.5, 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Time Frame

Baseline, Week 2, Month 1, 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Time Frame

Month 4.5, 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Time Frame

Baseline, Week 2, Month 1, 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Time Frame

Month 4.5, 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Time Frame

Baseline, Week 2, Month 1, 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Time Frame

Month 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.

Time Frame

Baseline, Week 2, Month 1, 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.

Time Frame

Month 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

FACIT-Fatigue Scale (FS):13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Time Frame

Baseline, Month 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

FACIT-FS:13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Time Frame

Month 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Time Frame

Baseline, Month 1, 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Time Frame

Month 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Standard deviation was not estimable since only 1 participant was evaluable.

No statistical analysis provided for Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6

34. Secondary:

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

Measure Type

Secondary

Measure Title

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3

Measure Description

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

Time Frame

Baseline, Month 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 [Units: Number of events]Mean (Standard Deviation)

Baseline: Doctor visit (n=119,121,111)

5.07 (5.00)

5.09 (5.10)

4.58 (3.82)

Baseline: NM practitioner visits (n=4,6,5)

5.75 (4.35)

4.83 (3.25)

21.40 (29.75)

Baseline: Hospital ER visit (n=14,5,9)

1.79 (1.53)

2.00 (1.73)

1.22 (0.44)

Baseline: Hospitalization (n=4,4,7)

1.25 (0.50)

1.00 (0.00)

1.14 (0.38)

Baseline: Outpatient surgery (n=6,4,8)

1.17 (0.41)

1.00 (0.00)

1.00 (0.00)

Baseline: Non-study diagnostic tests (n=34,32,32)

1.85 (1.02)

2.06 (1.72)

1.69 (0.97)

Baseline: RA related doctor visit (n=117,120,111)

1.46 (0.91)

1.18 (0.84)

1.44 (0.93)

Baseline: RA related ER visit (n=15,6,9)

0.67 (0.90)

0.67 (0.82)

0.89 (0.93)

Baseline: RA related diagnostic test (n=35,33,34)

0.71 (0.83)

0.79 (1.14)

0.82 (0.76)

Baseline: RA related hospitalization (n=4,5,7)

0.75 (0.96)

0.80 (1.10)

0.86 (0.69)

Baseline: RA related outpatient surgery (n=6,5,9)

0.33 (0.82)

0.80 (0.84)

0.89 (0.93)

Baselin:RA related NM visit (n=4,7,5)

1.25 (0.96)

0.57 (0.53)

1.00 (1.00)

Month 3: Doctor visit (n=89,99,93)

3.30 (2.91)

3.69 (3.73)

4.04 (4.59)

Month 3: NM practitioners visits (n=4,4,4)

36.25 (40.25)

5.00 (2.00)

8.75 (10.63)

Month 3: Hospital ER visit (n=7,8,8)

1.00 (0.00)

1.38 (1.06)

1.38 (0.74)

Month 3: Hospitalization (n=1,0,2)

1.00 [1]

NA [2]

1.00 (0.00)

Month 3: Outpatient surgery (n=7,3,4)

1.14 (0.38)

1.00 (0.00)

1.00 (0.00)

Month 3: Non-study diagnostic tests (n=22,22,26)

1.82 (1.65)

1.14 (0.35)

1.62 (1.27)

Month 3: RA related doctor visit (n=90,98,93)

1.16 (1.08)

0.82 (0.65)

1.13 (0.92)

Month 3: RA related ER visit (n=7,8,8)

0.43 (0.79)

0.00 (0.00)

0.75 (1.39)

Month 3: RA related diagnostic test (n=23,22,26)

0.30 (0.47)

0.23 (0.43)

0.35 (0.56)

Month 3: RA related hospitalization (n=1,0,2)

0.00 [1]

NA [2]

0.00 (0.00)

Month 3:RA related outpatient surgery (n=7,3,4)

0.43 (0.79)

0.67 (1.15)

1.00 (1.15)

Month 3:RA related NM visit (n=4,4,4)

0.75 (0.96)

1.25 (0.96)

1.25 (0.96)

[1]

Standard deviation was not estimable since only 1 participant was evaluable.

[2]

Data not available as no participant was evaluable for the treatment arm at the given time point.

No statistical analysis provided for Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3

35. Secondary:

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ]

Measure Type

Secondary

Measure Title

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6

Measure Description

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

Time Frame

Month 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 [Units: Number of events]Mean (Standard Deviation)

Month 6: Doctor visit (n=73,80,39,36)

3.26 (2.83)

3.84 (4.25)

3.64 (4.03)

4.97 (6.73)

Month 6: NM practitioner visit (n=1,4,1,2)

5.00 [1]

15.50 (10.63)

20.00 [1]

4.00 (0.00)

Month 6: Hospital ER visit (n=4,7,3,1)

1.25 (0.50)

1.43 (0.79)

1.67 (1.15)

1.00 [1]

Month 6: Hospitalization (n=2,1,2,1)

2.00 (0.00)

1.00 [1]

1.00 (0.00)

1.00 [1]

Month 6: Outpatient surgery (n=0,5,2,2)

NA [2]

1.00 (0.00)

2.50 (0.71)

1.50 (0.71)

Month 6: Non-study diagnostic test (n=15,16,13,7)

2.07 (2.02)

1.19 (0.54)

1.85 (0.99)

1.14 (0.38)

Month 6: RA related doctor visit (n=73,80,40,36)

1.10 (0.87)

0.86 (0.76)

0.85 (0.83)

1.00 (0.96)

Month 6: RA related ER visit (n=4,7,3,1)

0.00 (0.00)

0.00 (0.00)

0.00 (0.00)

0.00 [1]

Month 6: RA related diagnostic test (n=16,16,13,7)

0.44 (0.73)

0.00 (0.00)

0.31 (0.85)

0.29 (0.49)

Month 6: RA related hospitalization (n=2,1,2,1)

0.00 (0.00)

0.00 [1]

0.00 (0.00)

2.00 [1]

Month 6:RA related outpatient surgery (n=5,2,0,2)

0.00 (0.00)

2.00 (0.00)

NA [2]

0.00 (0.00)

Month6:RA related NM practitioner visit(n=1,4,1,2)

1.00 [1]

2.00 (1.63)

0.00 [1]

1.00 (1.41)

[1]

Standard deviation was not estimable since only 1 participant was evaluable.

[2]

Data not available as no participant was evaluable for the treatment arm at the given time point.

No statistical analysis provided for Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6

36. Secondary:

Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

Measure Type

Secondary

Measure Title

Number of Days as Assessed Using RA-HCRU at Baseline and Month 3

Measure Description

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.

Time Frame

Baseline, Month 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 [Units: Days]Mean (Standard Deviation)

Baseline: Hospital length of stay (n=4,4,7)

1.75 (0.96)

7.00 (7.57)

5.43 (3.78)

Baseline: Days in nursing home (n=1,1,1)

2.00 [1]

28.00 [1]

28.00 [1]

Baseline: Days devices/aids used (n=31,18,24)

122.94 (139.56)

100.28 (122.82)

94.63 (86.62)

Baseline: Days of work per week (n=39,46,41)

4.67 (1.24)

4.83 (1.29)

4.90 (1.18)

Baseline: Chores by housekeeper (n=20,18,24)

13.35 (20.32)

20.56 (32.53)

15.88 (23.45)

Baseline: Chores by family/friend (n=71,65,66)

27.55 (31.88)

26.31 (32.27)

27.38 (30.75)

Baseline: Days on sick leave (n=17,22,28)

19.76 (25.59)

13.09 (16.15)

23.71 (31.28)

Baseline: Days of part time work (n=6,6,11)

41.33 (40.41)

6.83 (4.96)

12.36 (16.20)

Baseline: Paid work, bothered by RA (n=36,40,32)

50.72 (63.36)

39.75 (32.85)

31.00 (30.79)

Baseline: RA related devices/aids used (31,20,24)

2.06 (1.59)

1.75 (1.48)

1.79 (0.88)

Month 3: Hospital length of stay (n=1,0,2)

12.00 [1]

NA [2]

11.00 (12.73)

Month 3: Days in nursing home (n=1,1,1)

9.00 [1]

21.00 [1]

21.00 [1]

Month 3: Days devices/aids used (n=21,10,26)

113.24 (102.65)

264.10 (429.48)

73.85 (70.60)

Month 3: Days of work per week (n=33,47,37)

4.94 (1.09)

4.89 (1.09)

4.65 (1.06)

Month 3: Chores by housekeeper (n=15,14,17)

13.00 (16.76)

16.93 (31.22)

10.12 (12.84)

Month 3: Chores by family/friend (n=50,41,52)

27.30 (31.13)

24.24 (32.54)

25.19 (36.03)

Month 3: Days on sick leave (n=11,13,16)

22.09 (28.51)

6.62 (4.94)

13.69 (20.16)

Month 3: Days of part time work (n=4,4,5)

8.25 (9.46)

9.25 (7.89)

8.20 (11.12)

Month 3: Paid work, bothered by RA (n=19,29,28)

26.58 (30.30)

17.76 (23.98)

30.54 (30.39)

Month 3: RA related devices/aids used (22,11,27)

2.09 (1.31)

3.00 (4.45)

2.04 (1.26)

[1]

Standard deviation was not estimable since only 1 participant was evaluable.

[2]

Data not available as no participant was evaluable for the treatment arm at the given time point.

No statistical analysis provided for Number of Days as Assessed Using RA-HCRU at Baseline and Month 3

37. Secondary:

Number of Days as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ]

Measure Type

Secondary

Measure Title

Number of Days as Assessed Using RA-HCRU at Month 6

Measure Description

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.

Time Frame

Month 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Number of Days as Assessed Using RA-HCRU at Month 6 [Units: Days]Mean (Standard Deviation)

Month 6: Hospital length of stay (n=2,1,2,1)

32.00 (33.94)

3.00 [1]

25.00 (21.21)

24.00 [1]

Month 6: Days in nursing home (n=2,0,0,2)

21.50 (0.71)

NA [2]

NA [2]

13.50 (2.12)

Month 6: Days devices/aids used (n=18,7,5,8)

141.28 (105.31)

68.43 (30.12)

182.40 (87.11)

75.00 (79.33)

Month 6: Days of work per week (n=34,36,20,14)

4.62 (1.33)

4.97 (1.00)

4.85 (0.99)

4.71 (1.49)

Month 6: Chores by housekeeper (n=8,9,9,5)

12.75 (13.21)

24.89 (36.09)

9.22 (10.73)

7.80 (4.55)

Month 6: Chores by family/friend (n=32,23,18,19)

28.91 (32.10)

18.83 (26.97)

19.33 (24.14)

17.63 (26.46)

Month 6: Days on sick leave (n=7,10,5,5)

21.00 (31.86)

10.40 (14.49)

9.20 (11.17)

42.60 (44.81)

Month 6: Days of part time work (n=3,3,0,3)

5.67 (8.08)

9.33 (5.03)

NA [2]

21.33 (33.49)

Month 6: Paid work, bothered by RA (n=21,19,12,11)

25.00 (32.76)

14.95 (20.85)

22.17 (31.98)

19.64 (21.73)

Month 6: RA related devices/aids used (19,8,5,8)

2.05 (1.22)

1.13 (0.64)

2.20 (0.84)

1.63 (1.19)

[1]

Standard deviation was not estimable since only 1 participant was evaluable.

[2]

Data not available as no participant was evaluable for the treatment arm at the given time point.

No statistical analysis provided for Number of Days as Assessed Using RA-HCRU at Month 6

38. Secondary:

Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

Measure Type

Secondary

Measure Title

Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3

Measure Description

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.

Time Frame

Baseline, Month 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 [Units: Hours per day]Mean (Standard Deviation)

Baseline: Home healthcare services (n=2,1,4)

5.00 (4.24)

3.00 [1]

7.25 (11.18)

Baseline: Work done (n=39,45,41)

9.41 (8.52)

8.18 (7.18)

8.98 (7.35)

Baseline: Chores by housekeeper (n=19,18,23)

4.68 (3.23)

3.83 (1.54)

4.78 (2.37)

Baseline: Chores by family/friend (n=71,63,66)

2.85 (1.89)

4.44 (11.21)

3.42 (2.61)

Baseline: Missed work due to RA (n=6,6,11)

2.67 (1.97)

3.17 (2.23)

7.55 (7.31)

Baseline: RA related home HC services (n=2,2,5)

1.50 (0.71)

0.50 (0.71)

0.80 (0.84)

Month 3: Home healthcare services (n=3,1,3)

4.00 (3.46)

2.00 [1]

9.33 (12.70)

Month 3: Work done (n=34,46,37)

7.97 (4.72)

9.20 (8.52)

7.76 (1.98)

Month 3: Chores by housekeeper (n=15,14,17)

4.00 (2.20)

3.71 (1.14)

5.41 (5.26)

Month 3: Chores by family/friend (n=50,41,49)

3.50 (3.72)

2.83 (2.57)

4.00 (5.34)

Month 3: Missed work due to RA (n=4,4,5)

3.00 (2.00)

6.25 (6.18)

7.80 (9.12)

Month 3: RA related home HC services (n=3,1,3)

1.33 (0.58)

1.00 [1]

1.67 (0.58)

[1]

Standard deviation was not estimable since only 1 participant was evaluable.

No statistical analysis provided for Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3

39. Secondary:

Number of Hours Per Day as Assessed RA-HCRU at Month 6 [ Time Frame: Month 6 ]

Measure Type

Secondary

Measure Title

Number of Hours Per Day as Assessed RA-HCRU at Month 6

Measure Description

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.

Time Frame

Month 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Number of Hours Per Day as Assessed RA-HCRU at Month 6 [Units: Hours per day]Mean (Standard Deviation)

Month 6: Home healthcare services (n=0,2,0,0)

NA [1]

2.00 (1.41)

NA [1]

NA [1]

Month 6: Work done (n=34,36,20,14)

7.53 (2.19)

10.36 (9.85)

7.65 (2.16)

10.21 (8.78)

Month 6: Chores by housekeeper (n=8,9,9,5)

2.88 (2.36)

3.78 (1.20)

5.00 (3.28)

5.00 (1.58)

Month 6: Chores by family/friend (n=31,22,18,19)

3.16 (2.57)

2.05 (1.05)

2.72 (1.67)

3.63 (5.58)

Month 6: Missed work due to RA (n=3,3,0,3)

4.00 (0.00)

2.67 (1.15)

NA [1]

2.00 (1.73)

Month 6: RA related home HC services (n=0,2,0,0)

NA [1]

1.00 (0.00)

NA [1]

NA [1]

[1]

Data not available as no participant was evaluable for the treatment arm at the given time point.

No statistical analysis provided for Number of Hours Per Day as Assessed RA-HCRU at Month 6

40. Secondary:

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

Measure Type

Secondary

Measure Title

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3

Measure Description

Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.

Time Frame

Baseline, Month 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 [Units: Units on a scale]Mean (Standard Deviation)

Baseline (n=73,76,72)

4.27 (3.20)

4.38 (3.12)

4.65 (3.23)

Month 3 (n=63,72,73)

3.52 (3.24)

3.51 (4.73)

4.04 (3.37)

No statistical analysis provided for Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3

41. Secondary:

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ]

Measure Type

Secondary

Measure Title

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6

Measure Description

Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.

Time Frame

Month 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).

Time Frame

Baseline, Month 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).

Time Frame

Month 6

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

No statistical analysis provided for Work Limitations Questionnaire (WLQ) Score at Month 6

44. Other Pre-specified:

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 [ Time Frame: Week 2, Month 1, 3 ]

Measure Type

Other Pre-specified

Measure Title

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 [Units: Participants]

Week 2: DAS28-3(CRP) <2.6 (n=127,125,124)

8

12

2

Week 2: DAS28-3(CRP) <=3.2 (n=127,125,124)

19

23

4

Month 1: DAS28-3(CRP) <2.6 (n=132,133,131)

14

7

3

Month 1: DAS28-3(CRP) <=3.2 (n=132,133,131)

27

42

11

Month 3: DAS28-3(CRP) <2.6 (n=132,133,131)

27

35

6

Month 3: DAS28-3(CRP) <=3.2 (n=132,133,131)

45

57

13

No statistical analysis provided for Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3

45. Other Pre-specified:

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 [ Time Frame: Month 4.5, 6 ]

Measure Type

Other Pre-specified

Measure Title

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 [Units: Participants]

Month 4.5: DAS28-3(CRP) <2.6

31

42

14

12

Month 4.5: DAS28-3(CRP) <=3.2

50

57

21

19

Month 6: DAS28-3(CRP) <2.6

35

36

11

9

Month 6: DAS28-3(CRP) <=3.2

57

59

23

19

No statistical analysis provided for Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6

46. Other Pre-specified:

Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 [ Time Frame: Month 3 ]

Measure Type

Other Pre-specified

Measure Title

Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 [Units: Participants]

Month 3: DAS28-4 (ESR) <2.6

8

14

2

Month 3: DAS28-4 (ESR) <=3.2

17

28

6

No statistical analysis provided for Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3

47. Other Pre-specified:

Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 [ Time Frame: Month 6 ]

Measure Type

Other Pre-specified

Measure Title

Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 [Units: Participants]

Month 6: DAS28-4(ESR) <2.6

13

20

7

2

Month 6: DAS28-4 (ESR) <=3.2

35

37

11

11

No statistical analysis provided for Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.